Integrated molecular diagnostic system for the point-of-care

用于现场护理的综合分子诊断系统

基本信息

  • 批准号:
    8056922
  • 负责人:
  • 金额:
    $ 24.19万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2011
  • 资助国家:
    美国
  • 起止时间:
    2011-09-30 至 2013-08-31
  • 项目状态:
    已结题

项目摘要

DESCRIPTION (provided by applicant): This STTR-AT-NIAID seeks to develop an integrated nucleic acid system based on research done by Catherine Klapperich's laboratory at Boston University. The BU lab-on-a-chip includes a micro solid phase extraction (<SPE) column, flap valves and hydrophobic vents to gate fluid movements through micro channels, and multiple reaction chambers for experimental replicates and control reactions. Dr. Klapperich's laboratory has successfully performed nucleic acid amplifications in the chip using BioHelix's isothermal amplification process. Biohelix's proprietary technology is called helicase-dependent amplification (HDA). It uses DNA helicases to separate DNA strands during exponential amplification at a constant temperature of 65:C. Like the polymerase chain reaction (PCR), HDA assays use a competitive internal control (i.e., a template DNA of known concentration spiked into the raw sample) that can be amplified by the same primers as the analyte, but detected separately; hence allowing us to detect amplification inhibitors in direct clinical samples. The objectives of Phase I are to: 1) modify the BU microfluidic device design to incorporate a lateral flow strip as a means of detecting amplification products using the naked eye; and 2) demonstrate the feasibility of performing integrated tests using the device from aim 1 using CT and NG spiked at 104 in 1 mL urine to establish proof of concept for integrated assays performed in a modified BU chip that includes a lateral flow strip. Our specific aims for Phase II will be to develop a lateral flow reader sub-system, integrate it with the BU instrument to build a pre-commercial looks-like / works-like prototypes, simplify chip design and fabrication to allow for pilot scale manufacturing, and implement a pilot scale manufacturing for the disposable at BioHelix / Quidel. At this stage Qiagen is the most likely manufacturer for the reader. At the conclusion of Phase II, we should be ready for clinical validation of the new assay system. PUBLIC HEALTH RELEVANCE: This Phase I STTR-AT-NIAID project seeks proof-of-concept project will focus on the most abundant sexually transmitted disease (STD) pathogens: Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). The scientific literature clearly shows that molecular testing is the most sensitive means of detecting CT and NG and the molecular CT/NG high throughput screening market is currently valued at over $300M/year. Moreover, CDC urges STD clinics to test patients with POC tests if health care workers suspect these patients are unlikely to return to the STD clinic to learn the results of the test. Unfortunately, there are no point-of-care (POC) CT NG molecular tests, and existing POC molecular testing systems like the GeneXpert are too costly for use in STD clinics. This proposed project would seek to remedy to this short coming. We propose to develop a low-cost POC molecular diagnostic system using a design developed by Dr. Catherine Klapperich's laboratory at Boston University (BU). Although the current BU disposable can perform our proprietary isothermal amplification reactions, it does not allow for low cost, instrument-free detection of amplification products; i.e., a fluorescence microscope can be used to detect product formation but this is not a commercially viable option. The device we envisage for Phase I will incorporate a lateral flow strip as a means of detecting the presence or absence of nucleic acid amplification products by simple visual inspection. BioHelix has experience in developing molecular tests using lateral flow based detection.
描述(由申请人提供):这个STTR-AT-NIAID旨在开发一个基于波士顿大学Catherine Klapperich实验室研究的综合核酸系统。BU lab- a-chip包括一个微固相萃取(<SPE)柱、挡板阀和疏水孔,用于阻止流体通过微通道运动,以及用于实验复制和控制反应的多个反应室。Klapperich博士的实验室已经成功地使用BioHelix的等温扩增过程在芯片上进行了核酸扩增。Biohelix的专利技术被称为解旋酶依赖性扩增(HDA)。它利用DNA解旋酶在恒温65℃的指数扩增过程中分离DNA链。与聚合酶链反应(PCR)一样,HDA分析使用竞争性内部控制(即,将已知浓度的模板DNA加入原始样品中),可以用与分析物相同的引物扩增,但单独检测;因此,允许我们在直接临床样品中检测扩增抑制剂。第一阶段的目标是:1)修改BU微流体装置的设计,将横向流动条作为使用肉眼检测扩增产物的手段;2)证明使用目标1中的设备进行集成测试的可行性,使用CT和在1ml尿液中添加浓度为104的NG,以建立在包括横向流动条的改良BU芯片中进行集成分析的概念证明。我们在第二阶段的具体目标是开发一个横向流量读取器子系统,将其与BU仪器集成在一起,以构建一个预商用外观/工作类似的原型,简化芯片设计和制造,以便进行中试规模生产,并在BioHelix / Quidel实施一次性产品的中试规模生产。在这个阶段,Qiagen是最有可能为读者提供的制造商。在II期结束时,我们应该为新的检测系统的临床验证做好准备。

项目成果

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科研奖励数量(0)
会议论文数量(0)
专利数量(0)

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Huimin Kong其他文献

Huimin Kong的其他文献

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{{ truncateString('Huimin Kong', 18)}}的其他基金

Low-cost, rapid quantitative Isothermal Assay for HIV RNA using ZNA
使用 ZNA 对 HIV RNA 进行低成本、快速定量等温测定
  • 批准号:
    8256266
  • 财政年份:
    2012
  • 资助金额:
    $ 24.19万
  • 项目类别:
Low-cost, rapid quantitative Isothermal Assay for HIV RNA using ZNA
使用 ZNA 对 HIV RNA 进行低成本、快速定量等温测定
  • 批准号:
    8426086
  • 财政年份:
    2012
  • 资助金额:
    $ 24.19万
  • 项目类别:
Integrated molecular diagnostic system for the point-of-care
用于现场护理的综合分子诊断系统
  • 批准号:
    8339922
  • 财政年份:
    2011
  • 资助金额:
    $ 24.19万
  • 项目类别:
Molecular tests for malaria that can be performed with unprocessed samples
可以使用未处理的样本进行疟疾分子检测
  • 批准号:
    7904569
  • 财政年份:
    2010
  • 资助金额:
    $ 24.19万
  • 项目类别:
Molecular tests for malaria that can be performed with unprocessed samples
可以使用未处理的样本进行疟疾分子检测
  • 批准号:
    8110641
  • 财政年份:
    2010
  • 资助金额:
    $ 24.19万
  • 项目类别:
Development of a novel whole genome amplification method that mimics nature
开发一种模仿自然的新型全基因组扩增方法
  • 批准号:
    7608568
  • 财政年份:
    2008
  • 资助金额:
    $ 24.19万
  • 项目类别:
Development of a novel whole genome amplification method that mimics nature
开发一种模仿自然的新型全基因组扩增方法
  • 批准号:
    7685520
  • 财政年份:
    2008
  • 资助金额:
    $ 24.19万
  • 项目类别:
Development of a novel whole genome amplification method that mimics nature
开发一种模仿自然的新型全基因组扩增方法
  • 批准号:
    7328472
  • 财政年份:
    2007
  • 资助金额:
    $ 24.19万
  • 项目类别:
Development of a one-step isothermal DNA amplification system for diagnostics
开发用于诊断的一步式等温 DNA 扩增系统
  • 批准号:
    7111405
  • 财政年份:
    2006
  • 资助金额:
    $ 24.19万
  • 项目类别:
Helicase-based rapid DNA diagnostic for Biodefense
基于解旋酶的生物防御快速 DNA 诊断
  • 批准号:
    6992501
  • 财政年份:
    2005
  • 资助金额:
    $ 24.19万
  • 项目类别:

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